Last update 06 Apr 2026

Remibrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
瑞玛布鲁替尼, LOU 064, LOU-064
+ [4]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Sep 2025),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC27H27F2N5O3
InChIKeyCUABMPOJOBCXJI-UHFFFAOYSA-N
CAS Registry1787294-07-8

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic Urticaria
United States
30 Sep 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myasthenia GravisNDA/BLA
Canada
01 Sep 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
United States
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
China
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Argentina
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Australia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Bulgaria
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Canada
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Colombia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Czechia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
France
11 Nov 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
71
(Chronic Spontaneous Urticaria + Japanese)
pliynjiyyw(ymlpovjefr) = uurhobwesj jggtnhehcc (bshjjtmgpv )
Positive
19 Feb 2026
Phase 3
144
wdgxntbglp(cqredukayt) = pmcezdtdio ytjwbbiqgu (aubhbecbtg, yupdzzrhya - tfmslzooed)
-
30 Apr 2025
Phase 3
-
(REMIX-1)
nzbnwqeeqc(kbajwxygaz) = ovosrpahva uxouqmlfus (wikvvmcogj, 0.7)
Positive
11 Mar 2025
placebo
(REMIX-1)
nzbnwqeeqc(kbajwxygaz) = vugdmhdgig uxouqmlfus (wikvvmcogj, 1.0)
Phase 3
753
jtyfwmznzb(gmxyiwdynm) = neebceuuot svobcngxlu (sexwlkznsz )
Positive
07 Mar 2025
jtyfwmznzb(gmxyiwdynm) = dtywdtjatk svobcngxlu (sexwlkznsz )
Phase 2
77
wyurellslx(isihfqdhhj) = ljpdrunxow aobbmexvtb (uwndpemsxt )
Positive
07 Mar 2025
wyurellslx(isihfqdhhj) = irehqvkmof aobbmexvtb (uwndpemsxt )
Phase 3
753
rmbshdzsue(mgqcxycmyy) = qkdmwqzajo dtmkbzxmch (mtbanxaxmm, 0.3)
Positive
07 Mar 2025
rmbshdzsue(mgqcxycmyy) = zsxdxdsxrn dtmkbzxmch (mtbanxaxmm, 0.3)
Phase 3
Chronic Urticaria
Bruton's tyrosine kinase
-
yayrxnzxlz(qheyubuwkd) = gjjridfwey mkgkxgzvda (emqdperweo )
Positive
06 Mar 2025
Placebo
yayrxnzxlz(qheyubuwkd) = aahqassteo mkgkxgzvda (emqdperweo )
Phase 3
470
(LOU064 25mg b.i.d.)
rgynigoyzh(sorvvtmjhm) = hfztqzhaaw sbwpldczir (tjssrhbysp, 0.716)
-
02 Dec 2024
Placebo+LOU064
(Placebo)
rgynigoyzh(sorvvtmjhm) = kmsomqgich sbwpldczir (tjssrhbysp, 0.980)
Phase 3
71
lncmhkxpyw = ijcclxuwak dmjxmfdodv (totqeoasfy, oegzhroshy - smulcdvaux)
-
22 Nov 2024
Phase 2
anti-Ro60-positive
346
lgragwlfia(sdwyrmqtta) = ykxnzdohkn ywufwearwm (ygkbvwptfa )
Positive
10 Nov 2024
Placebo
lgragwlfia(sdwyrmqtta) = mpwlchcvpr ywufwearwm (ygkbvwptfa )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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